Senior Manager Regulatory Affairs

Y-Axis; Greater London; Hybrid; GBP 85,000 - 110,000; Full time

Job summary

Park Street People Ltd. is recruiting a Senior Regulatory Manager for a pharmaceutical client. The role focuses on EMA regulatory affairs, leading strategy, and managing submissions across Europe.

You will liaise with EMA and authorities, guiding cross-functional teams to ensure compliance and timely market access. The ideal candidate has a strong background in EMA submissions and EU regulations, with proven leadership in regulatory projects and a track record of successful MAA submissions and

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline.
• Strong EMA regulatory affairs experience with a focus on submissions.
• Experience preparing MAA, CTD dossiers, variations and renewals.
• Knowledge of EU pharmaceutical regulations and guidelines.

Responsibilities

• Develop and execute regulatory strategies for Europe in line with EMA requirements.
• Lead EMA submissions, including MAA, variations, line extensions, and renewals.
• Act as primary liaison with EMA and competent authorities.
• Provide regulatory guidance to R&D, clinical, quality, and commercial teams.
• Monitor new regulations and industry trends to ensure compliance.
• Contribute to regulatory inspections and intelligence activities.

Skills

Regulatory affairs

EMA submissions

Cross-functional liaison

Quality compliance

Education

Pharmacy/Life Sciences degree

Job description

Senior Manager Regulatory Affairs at Park Street People

Full Time

Start Date

Immediate

Expiry Date

24 Nov, 26

0.0

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Pharmaceutical & Personal Care Products

Description

About the job

We are supporting a pharmaceutical company committed to delivering innovative therapies that improve patients’ lives in recruiting a Senior Regulatory Manager. Their global teams collaborate to bring cutting-edge solutions from concept to market while maintaining the highest standards of quality and compliance.

The Role:

We are seeking an experienced Senior Regulatory Manager with strong expertise in EMA regulatory affairs to join their dynamic team. This role offers the opportunity to lead regulatory strategy, manage submissions, and act as a key regulatory advisor for our product portfolio across the European region.

Key Responsibilities:

• Develop and execute regulatory strategies for products under development and marketed products in Europe, ensuring alignment with EMA requirements.
• Lead and manage EMA submissions, including MAA, variations, line extensions, and renewals.
• Act as primary liaison with EMA, competent authorities, and other regulatory bodies.
• Provide regulatory guidance to cross-functional teams (R&D, clinical, quality, commercial) throughout the product lifecycle.
• Evaluate and interpret new regulations, guidance, and industry trends to ensure ongoing compliance.
• Contribute to internal audits, inspections, and regulatory intelligence initiatives.

Qualifications & Experience:

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline.
• Strong regulatory affairs experience with a focus on EMA submissions.
• Proven experience in preparing and submitting MAA, CTD dossiers, variations, and renewals.
• Strong understanding of EU pharmaceutical regulations and guidelines.
• Excellent written and verbal communication skills.
• Demonstrated ability to lead projects and influence cross-functional teams.

Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.